Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine

NCT ID: NCT03760367

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2018-11-23

Brief Summary

The study investigates the effect of toothbrushing with a toothpaste containing blue covarine compared to a control toothpaste without blue covarine on tooth color. Participants brush their teeth once with either the blue covarine containing toothpaste or a control toothpaste for two minutes. Before and after brushing, tooth color is assessed with a spectrophotometer. Moreover, satisfaction of the participants with their tooth color is assessed using a numeric analogue scale before and after treatment.

The null hypotheses are that neither brushing with the toothpaste containing blue covarine nor brushing with the control toothpaste change a) the tooth color and b) the satisfaction of the participants with their tooth color.

Detailed Description

Participants are recruited by advertizing in several public areas in Aarhus, Denmark.

Written and oral information on the study is provided, eligibility criteria are checked, and informed consent is given by the participants.

The upper front teeth of the participants are cleaned with pumice and a rubber cup by operator A.

Participants look at the color of their upper front teeth with a mirror, in a room with controlled lighting conditions.

Thereafter, participants rate their satisfaction with the color of their teeth using an 11-point aesthetic numeric analogue scale.

Tooth color is assessed by operator B using a spectrophotometer (VITA Easyshade Advance) and a positioning device to standardize measurements. Measurements are performed in a room with controlled lighting conditions. VITA SYSTEM 3D-MASTER color, L*, a* and b* are recorded.

Participants are then randomly assigned to either the blue covarine toothpaste group or the control toothpaste group.

They are given a short video introduction to the Bass toothbrushing technique by operator C (caregiver).

Operator C provides a toothbrush and 1 g of either blue covarine toothpaste or control toothpaste, according to the randomization scheme.

Participants brush their teeth for two min, starting with the upper front teeth, and then rinse their mouth with tap water.

Thereafter, participants look again at the color of their upper front teeth with a mirror, in the same room as before treatment.

They rate their satisfaction with the color of their teeth using the 11-point aesthetic numeric analogue scale.

Moreover, they rate the color difference before and after treatment on an 11-point aesthetic numeric analogue scale.

Again, tooth color is assessed by operator B using a spectrophotometer (VITA Easyshade Advance) and a positioning device to standardize measurements. Measurements are performed in the room with controlled lighting conditions. Again VITA SYSTEM 3D-MASTER color, L*, a* and b* are recorded.

The null hypotheses of the study are that neither brushing with the toothpaste containing blue covarine nor brushing with the control toothpaste change a) the tooth color and b) the satisfaction of the participants with their tooth color.

Conditions

Tooth Whitening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Blue Covarine Toothpaste

After a short video introduction to the bass technique, participants brush their teeth once with a silica toothpaste containing blue covarine (Pepsodent White Now Gold, 1 g) for 2 min, starting with the upper front teeth. Thereafter, participants rinse their mouth with of tap water.

Group Type: EXPERIMENTAL

Blue covarine toothpaste

Intervention Type: OTHER

2 min toothbrushing with 1 g of Pepsodent White Now Gold

Control Toothpaste

After a short video introduction to the bass technique, participants brush their teeth once with a silica toothpaste (Colgate Advanced Whitening, 1 g) for 2 min, starting with the upper front teeth. Thereafter, participants rinse their mouth with of tap water.

Group Type: ACTIVE_COMPARATOR

Control toothpaste

Intervention Type: OTHER

2 min toothbrushing with 1 g of Colgate Advanced Whitening

Interventions

Blue covarine toothpaste

2 min toothbrushing with 1 g of Pepsodent White Now Gold

Intervention Type: OTHER

Control toothpaste

2 min toothbrushing with 1 g of Colgate Advanced Whitening

Intervention Type: OTHER

Other Intervention Names

Pepsodent White Now Gold; Colgate Advanced Whitening

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Dental caries in the upper front teeth
• Intrinsic stain of the upper front teeth, including tetracyclin stains, fluorosis, and staining due to pulpitis or pulp necrosis
• Dental restorations in the upper front teeth, including fillings, veneers, crowns, and root canal fillings
• Dental anomalies of the upper front teeth, including molar incisor hypomineralisation, amelogenesis imperfecta, and dentinogenesis imperfecta

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian Schlafer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Department of Dentistry and Oral Health

Locations

Aarhus University, Department of Dentistry and Oral Health

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

IOOS_TA_01_2018

Identifier Type: -

Identifier Source: org_study_id